Abstract 824TiP
Background
Endometrial carcinoma is the most common malignancy of the female reproductive tract. Most cases are diagnosed at an early stage due to the appearance of symptoms such as postmenopausal bleeding. However, endometrial carcinoma carries a poor prognosis when it recurs after previous definitive treatment or when diagnosed at an advanced stage.The 5-year survival rate for FIGO III is approximately 57-66% and for FIGO IV is approximately 10-20%.The combination of PARP inhibitors and PD1/PD-L1 has the theoretical support of preclinical molecular biology. In recent years, a large number of basic studies and preclinical models have confirmed that this combination therapy has superimposed or even synergistic effects on multiple levels.This study intends to explore the efficacy and safety of anti-PD-1 antibody combined with niraparib in the treatment of recurrent or advanced endometrial cancer.
Trial design
The SINI (NCT04885413) trial was to evaluate the safety and activity of Niraparib combined with Sintilimab in patients with recurrent/advanced endometrial cancer.37 patients were planned to be enrolled. Nine cases were enrolled in the first stage. When the number of effective cases was ≤1, the combination therapy was considered to be no better than the single drug, and the trial was terminated. Otherwise, continue with the enrollment of 25 cases in the second stage. Assuming a loss rate of 10%. Key eligibility criteria include：patients were aged 18–70years, histologically confirmed endometrial epithelial carcinoma, at least one measurable lesion by RECIST1.1 on CT and had an ECOG performance status of 0-1. Patients received oral niraparib 200 mg once daily and intravenous sintilimab 200mg every 3 weeks until disease progression, intolerable toxicity, or withdrawal of consent. The primary endpoint was the overall respond rate (ORR) assessed by RECIST version 1.1. Secondary endpoints included disease control rate (DCR),duration of response (DOR) and safety.
Clinical trial identification
NCT04885413; Initial Release: 04/23/2020.
Editorial acknowledgement
Legal entity responsible for the study
J. Li.
Funding
Zai Lab (Shanghai) Co., Ltd.
Disclosure
All authors have declared no conflicts of interest.